Back to resultsTranscranial Direct Current Stimulation in Post-stroke Fatigue (TIPS)
Primary Purpose
Fatigue, Stroke
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Anodal tDCS
sham tDCS
Sponsored by
About this trial
This is an interventional basic science trial for Fatigue
Eligibility Criteria
Inclusion Criteria:
Diagnosed with stroke at least 3 months post-stroke
Exclusion Criteria:
Other neurological conditions on Anti-depressants severe motor impairment (affected hand grip <60% unaffected hand) severe cognitive impairment (unable to follow instructions, or give informed consent) scored >11 in the depression sub-section of HADS questionnaire contraindications for TMS or tES
Sites / Locations
- 33 Queen Square, Institute of Neurology, UCL
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Anodal tDCS
sham tDCS
Arm Description
40 minutes of 2mA intensity direct current stimulation
40 minutes of 0mA intensity. the session starts with a ramp up to 2mA, but machine is switched off after 2 minutes of stimulation.
Outcomes
Primary Outcome Measures
Fatigue Severity Scale - 7
a questionnaire based fatigue scale
Secondary Outcome Measures
Resting Motor Threshold
This is a measure of cortical excitability as measured by transcranial magnetic stimulation
Input-output curves
This is a measure of cortical recruitment as measured by transcranial magnetic stimulation
Perceived effort - Explicit
A VAS scale associated with a grip task
Perceived effort - Implicit
A novel line length estimation task
Full Information
NCT ID
NCT04634864
First Posted
November 12, 2020
Last Updated
November 17, 2020
Sponsor
University College, London
1. Study Identification
Unique Protocol Identification Number
NCT04634864
Brief Title
Transcranial Direct Current Stimulation in Post-stroke Fatigue
Acronym
TIPS
Official Title
tDCS in Post-stroke Fatigue: a Double Blind, Sham-controlled, Bilateral Anodal Motor Cortical Stimulation Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
August 8, 2019 (Actual)
Study Completion Date
August 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a double-blind, sham-controlled, anodal tDCS study to understand the effect of increasing motor cortex excitability on post-stroke fatigue.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Stroke
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anodal tDCS
Arm Type
Active Comparator
Arm Description
40 minutes of 2mA intensity direct current stimulation
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
40 minutes of 0mA intensity. the session starts with a ramp up to 2mA, but machine is switched off after 2 minutes of stimulation.
Intervention Type
Device
Intervention Name(s)
Anodal tDCS
Intervention Description
40 minutes of 2mA intensity direct current stimulation was delivered over both the right and left motor cortex simultaneously
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
The stimulator was switched off after 2 minutes of stimulation.
Primary Outcome Measure Information:
Title
Fatigue Severity Scale - 7
Description
a questionnaire based fatigue scale
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Resting Motor Threshold
Description
This is a measure of cortical excitability as measured by transcranial magnetic stimulation
Time Frame
1 day
Title
Input-output curves
Description
This is a measure of cortical recruitment as measured by transcranial magnetic stimulation
Time Frame
1 day
Title
Perceived effort - Explicit
Description
A VAS scale associated with a grip task
Time Frame
1 day
Title
Perceived effort - Implicit
Description
A novel line length estimation task
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with stroke at least 3 months post-stroke
Exclusion Criteria:
Other neurological conditions on Anti-depressants severe motor impairment (affected hand grip <60% unaffected hand) severe cognitive impairment (unable to follow instructions, or give informed consent) scored >11 in the depression sub-section of HADS questionnaire contraindications for TMS or tES
Facility Information:
Facility Name
33 Queen Square, Institute of Neurology, UCL
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
33598767
Citation
De Doncker W, Ondobaka S, Kuppuswamy A. Effect of transcranial direct current stimulation on post-stroke fatigue. J Neurol. 2021 Aug;268(8):2831-2842. doi: 10.1007/s00415-021-10442-8. Epub 2021 Feb 17.
Results Reference
derived
Learn more about this trial
Transcranial Direct Current Stimulation in Post-stroke Fatigue
We'll reach out to this number within 24 hrs